PFO Closure Device Market –
Restrain
PFO
Closure Device Market is expected to be hindered by product discontinuation
or recall. For instance, in 2013, W. L. Gore & Associates, Inc,
discontinued its product GORE HELEX Septal Occluder, as a result of sued for
patent infringement. Moreover, in 2013, St. Jude Medical recalled Amplatzer PFO
Occluder, assigned as Class I tagged product recall by FDA.
Patent Foramen Ovale (PFO) is a
medical condition wherein tissue flap in the wall between left and right atrium
remains persistently open, allowing a small amount of blood to pass from the
right side of the heart to the left side of the heart. PFO closure device are
implantable device used to treat PFO through a minimally invasive,
catheter-based technique, implicated in a number of pathological states,
including cryptogenic strokes, transient ischemic attacks, migraine with auras,
decompression sickness, and severe refractory hypoxemia. PFO closure device
market is driven by high incidence rate for ischemic stroke and new product
launches.
PFO Closure Device Market –
Driver
PFO closure device market is
majorly driven by the high incidence of ischemic stock. Stroke is the second
most common cause of death in the world. According to the American Stroke
Association, 2016, annually more than 795,000 people in U.S. suffer from
stroke, of which about 87% of stroke are ischemic strokes. Furthermore,
increasing number of congenital heart disease is expected to propel growth of
the PFO closure device market.
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For instance, according to
American Heart Association, around 40,000 infants are born with a congenital
heart defect in the U.S. annually and around 2 to 3 million individuals are
suffering from congenital heart defect. Moreover, increasing adoption of life
style related risk factors such as alcohol, smoking, drugs or sedentary life
style is expected to elevate the risk of stroke incidence.
Moreover, new product launches
are expected to boost growth of the PFO closure device market during the
forecast period. For instance, in April 2018, W. L. Gore & Associates, Inc.
received the US FDA approval for its GORE CARDIOFORM Septal Occluder for PFO closure
to prevent recurrent ischemic stroke. The study claimed 77% reduction in
recurrent ischemic stroke when PFO closure was combined with antiplatelet
therapy, as compared to antiplatelet therapy. Moreover, in 2016, Amplatzer PFO
Occluder device was reintroduced after product recall with FDA approval to
reduce stroke risk for patients with prior cryptogenic stroke. Furthermore,
increasing clinical trials for new device is expected fuel growth of the PFO
closure device market. For instance, as on 2016, Lifetech Scientific (Shenzhen)
Co., Ltd. was conducting its Post Market Clinical Follow-up study for its
device named IrisFIT PFO Occluder for the indication of PFO.
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PFO Closure Device Market -
Regional Analysis
Based on geography, the PFO
closure device market has been segmented into North America, Latin America,
Europe, Middle East, Asia Pacific, and Africa. North America holds dominant
market share attributed to high incidence of ischemic stroke. Furthermore, Asia
Pacific is expected to fastest growing PFO closure device market due to
increasing awareness among the population about PFO. For instance, PFO Funding Organization,
Australia-based not for profit organization, works to increase public and
physician awareness of the medical condition called patent foramen ovale (PFO)
or ‘hole in the heart’ and its importance to cardiovascular and neurological
health.
PFO Closure Device Market –
Competitive Analysis
Key players operating in PFO
closure device market includes AGA Medical, Abbott (previously known as St Jude
Medical, Inc.), WL Gore and Associates, Swissimplant AG, and Occlutech.
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